Document Coordinator

The Document Coordinator supports the process for creating, reviewing, approving, distributing, controlling and maintaining documentation to ensure effective and efficient application of GMP.

Documentation within this process includes, but is not limited to, manufacturing and packaging, laboratory, and general operations.

The successful candidate may be required to work 12 / 7 shift (extended day shift 7am - 7pm).

A typical shift might include, but is not limited to, the following :

• Developing guidance for document hierarchy concepts and implementing changes
• Providing guidance for new document type creations based on existing scenarios
• Recommending approval strategies to customers including release strategies
• Coordinating multiple pre-fixes and / or processes across multiple areas and sites
• Executing tasks associated with EDMS outages
• Managing (with supervision) document requests including intake, coordination, editing, review, and release
• Executing the different steps associated with the lifecycle of one or more records including issuance, tracking, and reconciliation of Master Batch Records, Batch Sheets, Protocol Performance Copies, Labels, Logbooks, Keys etc.
• Performing verification of records ensuring all required information is present, accurate, and compliant against procedures prior to issuing to receiving area
• Monitoring inventory of issued documentation
• Performing metrics analysis required for understanding of system or process performance, or investigation activities, and identification of reactive and proactive changes
• Authoring reports on a pre-defined basis needed to support process understanding, customer information requests, and visibility of organization activities
• Generating concepts for displaying data from different departmental activities into visual management tools
• Serving as integral resource or team member for regulatory and internal audit and inspection logistics
• Leveraging subject matter knowledge to assist in problem solving and investigation efforts
• Identifying areas for continuous improvement for processes based on experience and customer feedback

This role might be for you if :

• You are knowledgeable in document databases and other electronic document management tools (e.g. eDocCompliance, FileMaker Pro)
• You demonstrate strong attention to detail and organizational skills
• You possess the ability to work independently with moderate supervision and in a team environment
• You work well under time restraints

To be considered for this opportunity you should have a Bachelor’s degree with 2 years relevant experience or equivalent combination of education and experience .

Experience with Microsoft Office (Word, PowerPoint, Excel, Access, Outlook) is desirable.

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